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Good day, ladies and gentlemen. And welcome to the Isoray, Inc. Q1 FY 2023 Call. At this time, all participants have been placed on a listen-only mode and the floor will be open for questions-and-comments after the presentation. It is now my pleasure to turn the floor over to your host, Mark Levin. Sir, the floor is yours.

Thank you, Operator. Good afternoon. And thank you for joining us today for the Isoray fiscal first quarter 2023 earnings call for the quarter ended September 30, 2022. Before we get started, I will take a few minutes to read the forward-looking statement. Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. When used in this conference call, words such as will, believe, expect, anticipate, encourage and similar expressions as they relate to the company or its management, as well as assumptions made by and information currently available to the company’s management identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs about future events as of today, November 10, 2022, including statements regarding the anticipated synergies and benefits of the proposed merger with Viewpoint Molecular Targeting. As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstances, and the company undertakes no obligation to and expressly disclaims any obligation to update or alter its forward-looking statements, whether resulting from such changes, new information, subsequent events or otherwise. Risks and uncertainties include whether the proposed merger is completed, and if so, whether the anticipated benefits of the merger are realized, whether an event occurs, including an event with a material adverse effect or a condition to closing the merger is not satisfied, such as failure to obtain approval from Isoray’s stockholders that results in a failure to complete the merger, whether Isoray and Viewpoint are able to successfully integrate their businesses, and whether restrictions on Isoray’s business during the pendency of the merger harm our business. Additional information concerning forward-looking statements is contained under the headings of Safe Harbor Statement and Risk Factors listed from time-to-time in the company’s filings with the Securities and Exchange Commission. We will begin today’s call with Lori Woods, Isoray’s Chief Executive Officer; and Thijs Spoor, Chief Executive Officer of Viewpoint Molecular Targeting; and then Jonathan Hunt, Isoray's Chief Financial Officer will discuss the fiscal first quarter 2023 financial results. Following their prepared remarks, we will take questions from our analysts and institutional investors. I will now turn the call over to Lori.

Thank you, Mark. Good afternoon, and thank you for joining us today for Isoray's fiscal first quarter 2023 earnings conference call for the quarter ended September 30, 2022. Joining us again today is Thijs Spoor, Chief Executive Officer of Viewpoint Molecular Targeting. Together, we will be discussing the proposed merger of our two companies and why we believe the combination represents an attractive opportunity for investors. Following our prepared remarks, our Chief Financial Officer, Jonathan Hunt, will provide a more detailed review of our fiscal first quarter financial results. Before we discuss the proposed merger with Viewpoint, I have a brief update on our isotope supply and our attendance at ASTRO, the American Society of Therapeutic Radiation Oncologists. The isotope supply chain issues that impacted us during the first quarter of 2023 have been resolved. The second reactor that was down for planned maintenance came back online in early September and has supplied all of our isotope needs since then. Additionally, I am happy to report that the other reactor that experienced the unplanned disruption is back online, and we anticipate receiving our first isotope shipment from it early next month. I am also pleased to update you on our recent participation at ASTRO's Annual Meeting. It was noteworthy for a few reasons. This was the first ASTRO meeting since the pandemic that had a significant in-person attendance. It was very gratifying to be able to connect with our customers and colleagues again and to see the interest from physicians in the development of theranostic radiopharmaceuticals such as Lead-212. We participated in discussions and heard from many different constituents that the time has come for this technology to make significant inroads in the treatment of a variety of cancers. We had very interesting discussions with leading research institutions on proposed clinical trial work, both with Cesium-131 and Lead-212. We're very excited about the follow-up planned with these institutions. Now turning to the proposed merger. We believe that the proposed merger with Viewpoint presents an exciting transformational opportunity for Isoray and our stakeholders. To fully appreciate what this opportunity represents, I believe it is helpful to look at this merger from the perspective of where we've been and where we stand now. Isoray has been a company founded on the merits of Cesium-131 brachytherapy for the treatment of cancers. As we evolve, our expansion beyond prostate cancer to the treatment of other cancers throughout the body, reflected a strategic approach to growing the company and treatment opportunities for patients and their doctors. When we announced the Viewpoint transaction, I shared with you that we had undertaken a rigorous evaluation process, bringing in industry experts to help us analyze our target markets of radiation, theranostic radiopharmaceuticals and imaging technologies. Our research and due-diligence was based on our determination to continue to build on Isoray's leadership role in brachytherapy while positioning ourselves at the forefront of the next major advancements in cancer treatment. At the same time, we were equally determined to remain committed to continuing to bring precise personalized targeted solutions that advance options for patients. The proposed merger does just that as we believe it provides a pipeline of future products supporting that commitment to our patients, assuring the continued growth of Isoray and increasing shareholder value. We believe the merger represents a pivot for Isoray going forward given the early-stage nature of Viewpoint's theranostic radiopharmaceutical portfolio. A significant amount of the combined company's resources and investments going forward will be focused on the development of Viewpoint's pipeline. We believe that based on the compelling results of the early-stage data and the overall market opportunity that exists for Viewpoint's portfolio, investing in the development of Viewpoint's product pipeline will be richly rewarded over time. Those rewards will come as clinical milestones are achieved and innovative products are brought to market. Now I will turn the call over to Thijs to talk further about the recent developments at Viewpoint and the opportunities that we believe their pipeline represents.

Thanks, Lori. The past year has been very exciting for Viewpoint. Highlights of key developments over the past few months include an important progress in our clinical stage theranostic radiopharmaceuticals, additional grant awards, new compound pipeline progress, increased manufacturing capacity and the ability to attract really strong talent. These achievements come against the backdrop of increasing deal flow and product approvals in the radiopharmaceutical space. It is anticipated that the global radiopharmaceuticals market will grow again by about 7% in 2021 to reach about US$6 billion. By 2031, it is projected that radiotherapeutics will represent around 75% of the estimated $33 billion nuclear medicine market with a compound annual growth rate of 18%, which exceeds that expected for prescription oncology drugs according to [MedRe's Intel] report from last year. The magnitude of the significant growth is translating into major M&A activities with over $17 billion of transactions in the past 7 years. These include Bayer's acquisition of Algeta for its prostate cancer treatment, which is radium labeled Xofigo, that was a $2.9 billion acquisition. Novartis acquired Advanced Accelerator Applications in its neuroendocrine tumor treatment, which is lutetium 177 label data in January 2019 for a total of $3.9 billion. And again, Novartis in 2018 brought up Endocyte whether it's prostate cancer drug, which is the TCM-177- labelled PSMA for $2.1 billion. Our drug and development for the treatment of melanoma, VMT01 is breaking new ground based on some remarkable data in imaging therapy. We did animal experiments using the drug on its own, one as monotherapy as well as in combination with other approved cancer drugs. Monotherapy gave very strong results from the highly aggressive form of the melanoma. When using combination though, we saw some of the animals getting complete responses, meaning that the disease appear to have been completely managed, and they were able to live out the remainder of their lives. The data has been published and receiving great critical review. In fact, it led us to review the proceeding at $2 million grant from the National Cancer Institute earlier this year to continue to study this extraordinary combination effect. As previously announced, Viewpoint's melanoma drug is in the clinical stage of testing, meaning we're evaluating it in humans. We have previously announced in July last year that we are going to be enrolling patients in the TIMAR1 study at the Mayo Clinic in Rochester, Minnesota. Enrollment in this imaging-only study has closed. We are very excited by these results, and we are moving on to the next phase of development, which will involve looking at treating patients with melanoma if they have a high expression of a specific receptor called MC1R. During the webcast, we hosted on October 19. We've got a sneak peek into some of the results as presented by Dr. Geoffrey Johnson, who is the principal investigator of the study. With the various imaging versions of this drug using both PET and SPECT imaging, we saw high levels of uptake of the drug in certain melanoma patients, but not in others. We saw a very strong safety profile in all subjects for the imaging version of this drug. We are really encouraged by the results, indicating that the scans can discriminate between patients who are unlikely to respond due to the lack of the MC1R receptor and those who could potentially benefit. So rather than taking a hit or miss approach to giving patients cancer therapies and hoping they work, a negative scan would give doctors and patients the confidence to avoid the cost and side effects of therapies with the low probability of working. We are more excited though about the results that showed patients who had specific melanoma tumors where the therapeutic version of the drug would be likely to give a strong response. If there's a strong image of melanoma tumors on the scan, it is logical to conclude that those tumors that light up on the scan would then be expected to be damaged or destroyed by the lead-212, the therapeutic version of the isotope on the drug. This combination of using lead-203 to image and lead-212 to treat a tumor is a theranostic approach integrating the diagnostic and therapeutic with isotopic twins in the same element. With targeted alpha therapies such as those being developed by Viewpoint, it is not just the tumor destruction, but something called the bistandard effect where other similar tumors in the body also get destroyed. We're working really hard right now to get a therapeutic trial in human started over the next several months, so that we can begin to share preliminary results on some of the patients receiving these targeted therapies sometime in calendar year 2023. Simply put, as we think about the progress we have made, we have seen that we can image mice and then predict which mice will respond to treatment, and we have treated mice in mono combination therapies. In humans, we have seen which patients we can image with the specific form of melanoma and the next step will be to confidently start to treat patients with have positive scans using the same drug that would treat them. We are working on initiating our therapeutic trials in melanoma patients with the goal to enroll and begin treating in 2023. Because these early-stage trials are not blinded, we expect to be able to communicate the initial results from these studies at regular intervals throughout 2023. Changing gears, our other exciting clinical stage program, VMT-alpha-NET, is being developed for use in neuroendocrine tumor treatment. Initially, we showed great results of imaging and subsequently treated in animals using the drug, which uses the same isotope applied for imaging and therapy treatment as the VMT01 does for metastatic melanoma. Our scientists decided to lean in on this and do a straight head-to-head study looking at our radiopharmaceutical and the currently approved lutetium Lu 177 dotatate, which Novartis markets as Lutathera in comparison with leading the animals untreated. As a reminder, Lutathera was the first rate pharmaceutical approved as a peptide receptor radionuclide therapy, receiving EMA approval in 2017 and FDA approval in 2018 and is currently on track to achieve between $500 million and $1 billion in annual sales. Some highlights of our head-to-head results with Lutetium dotatate were presented at the European Association of Nuclear Medicine Meeting in October. The results show that compared to doing nothing, Lutetium dotatate gave the mice a significant survival benefit of a few weeks, which loosely translates into 1 to 2 years in humans. When we looked at our drug in the exact same model, however, we were able to show 100% complete response rate, which persisted for the remainder of their natural lines. We expect to have additional results from these studies as well as the long-term safety data published in the first half of 2023. What's so exciting about this data though is that when Viewpoint sent this impressive animal response data to the FDA, we are granted Fast Track designation for this program on September 29, 2022. This is critical because the FDA's Fast Track designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious condition that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over other available therapies, act by a different mechanism of action than available therapies or have a benefit in patients who are unresponsive to or intolerant of available therapy. Program that receive Fast Track designation are entitled to more frequent interactions with the FDA on drug development plans as well as eligibility for accelerated approval priority review and rolling review. What this means for us is that we will be allowed a high frequency of communication with the FDA assuring us that questions and issues can be raised and resolved quickly. This designation often leads to early drug approval and earlier access by patients to novel therapies. And the ability to engage with the FDA in real time allows significant time savings in study conduct and adaptive design and the ability to adjust the regulatory strategy in real time your response to patient enrollment. Another development this quarter was the recent publication which showed amazing images of our VMT-alpha-NET drug in an end stage neuroendocrine patient who is refractory after six cycles of the T cell dotatate Lutathera. What the images showed was that the patient's tumors displayed amazing uptake at one hour and 21 hours post injection, showing that when given as a therapy, the drug would accumulate in the tumor and nowhere else, allowing all the residual drug to be eliminated to the kidneys into the bladder. The later scan is also helpful as it shows that over the effective two day duration of the drug, the alpha particles which will be delivered directly to the tumor would not be a boost in the body that seems to be the result of some of the other approaches we have seen. With all the validating science and outside interest in VMT-alpha-NET, we are working on initiating therapeutic trials with the goal to have patients enrolled and treated in 2023 just as with our melanoma program. We're also really excited about the progress of our pipeline. Viewpoint scientists have received strong validation from the melanoma near endocrine programs, but the company is turning into a drug discovery platform that we believe will be extremely fruitful. We have proven that we can regulated identify cancer target develop highly sensitive peptides to those targets on cancer cells. And then when we change isotopes to the lead-212 version, that we can destroy tumor cells that we previously identified on the imaging scan. By changing the peptides to select for other cancers, we can then target very specific diseases. Our scientists are looking at some extremely interesting cancer markers where we are now demonstrating such compelling images that we may be able to advance programs and additional indications into the clinic as early as next year. In summary, Viewpoint is finishing off this calendar year with many major pluses. We continue to attract and retain extraordinary drug development talent, people with a shared commitment to treat cancer from the inside out. Our successes continue to be recognized by being awarded incremental grants from various agencies to develop our therapies in more and more settings. We've been able to demonstrate that our platform can deliver novel therapies with long patent lives and that are iterating our drug design we can image cancers and then treat what we image. We have shown this by bringing to clinical trials treatments for two different cancer types, melanoma and neuroendocrine tumors. We're also looking forward to potentially expanding the platform quite rapidly with targeted alpha therapies and additional tumor types. As we look ahead to the proposed merger with Isoray, we believe there is much to be excited about. The merger brings together both complementary skill sets and a complementary approach to treating cancer that continues its legacy to precise personalized targeted therapies which holds a great promise where we can build together in 2023 and beyond. With that, I'll turn it over to Jonathan.

Thank you, Thijs, for that update on Viewpoint's activities. We are excited about the future of the combined companies and the markets we can reach. I am now going to discuss some of the financial information that was contained in our press release for the fiscal first quarter ended September 30, 2022 that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around November 11. Revenue for the first quarter ended September 30, 2022, decreased to $1.72 million versus $2.56 million for the same period last year. Prostate brachytherapy revenue decreased 41% versus the first quarter of fiscal 2022. First quarter revenue was comprised of 68% for prostate brachytherapy with the balance or 32% of revenue attributed to other brachytherapy. The year-over-year decline in revenue was primarily the result of the isotope supply chain disruption in August that limited our ability to supply customers with product during parts of that quarter. Total other brachytherapy revenue only declined 7% versus the first quarter of fiscal '22 as sales to treat brain cancers, which includes sales to GT Medical Technologies increased 15% year-over-year despite the supply disruption. Gross profit as a percentage of revenues for the first quarter ended September 30, 2022, was 24.1% compared to 40.1% for the quarter ended September 30, 2021. The gross margin decline was primarily the result of the decrease in sales resulting from the lack of isotope within the quarter, which exceeded the decrease in total cost of product sales versus the year ago quarter. First quarter gross profit dollars of $414,000 decreased 60% when compared to the same period last year, total operating expenses, consisting of research and development, sales and marketing and general and administrative increased to $4.6 million versus $3.3 million in the first quarter of 2022. Total R&D expense increased 1% versus the comparable prior year quarter to $708,000. The increase in total research and development expenses was primarily the result of increased payroll and benefits expense due to annual merit increases and bonuses related to certain merger-related milestones, which was largely offset by lower market research and consulting expenses versus the prior year comparable period. Sales and marketing expenses increased 5% versus the comparable prior year quarter to $800,000. The increase in sales and marketing expenses was driven primarily by increased payroll and benefits expense due to annual merit increases, new hires to replace sales professionals that left in fiscal 2022 and an increase in compensation payments to support sales professionals during the unplanned service disruption to ensure they did not leave due to the competitive labor market. G&A expenses of $3.1 million represented an increase of 69% versus the fiscal first quarter 2022. The year-over-year increase was primarily the result of legal expenses, third-party due diligence consulting and investment banking expenses related to the merger with Viewpoint Molecular Targeting Inc. Also contributing to the increase were payroll and benefit expenses due to annual merit increases, bonuses related to merger-related milestones, D&O insurance expense, increased audit and legal fees and increased travel. The first quarter net loss was $4.07 million versus a net loss of $2.4 million during the same prior year period. The net loss per basic and diluted share was $0.03 versus the net loss of $0.02 for the prior year fiscal first quarter. Basic and diluted share results are based on weighted average shares outstanding of approximately $142.1 million at fiscal first quarter 2023 versus $141.9 million for the prior year period. As of September 30, 2022, the company had cash, cash equivalents and short-term investments that totaled $54.1 million or approximately $0.38 per share compared to $55.9 million at the end of fiscal year 2022 ended June 30, 2022. The company has zero long-term debt. Shareholders' equity at the end of the fiscal first quarter 2023 totaled $57.7 million versus $61.3 million at the end of fiscal year 2022. I will now turn the call over to the operator to take questions from our analysts and institutional investors.

[Operator Instructions] Your first question for today is coming from Mike Ott at Oppenheimer.

Good afternoon, Lori, Thijs and Jonathan thanks for taking our questions. Starting with Lori and Jonathan, I guess, good to hear the Russian reactors are back online wondering if it's possible to quantify the impact on F1Q just reported and do you see any additional impact on revenues here in F2Q?

Hi, Mike. Yes, there was definitely impact. It was really in the revenues we were essentially down without much isotopes through much of August and going into the beginning of September when the supply began again. In terms of the impacts, there's nothing that we have quantified there. But yes, there was a big hit. We would have expected revenue to more in line at least with the last kind of several quarters going backwards, but that obviously did not happen due to the supply issues.

Okay. That makes sense. That's helpful, Jonathan. Thanks. And then Thijs, you mentioned in melanoma, there'd be some updates coming throughout 2023 what kinds of data do you expect to report out on?

Thanks for the question. There's a few bits of data that we expect to come out first is on the TMR-1 study, so that TMR-1 was the imaging only one that was conducted at Mayo Clinic. So we expect to have the full results of that study published and read out including all the safety data and all the comprehensive data. But we're just excited about two is that we're kicking off at activities to begin treating patients with melanoma. And so, we recently expect to have patients both imaged and treated with melanoma in the U.S. next year. And because the study is open label, we'll be seeing it as we go and we'll be able to sort of communicate out how that therapy is progressing. The reason why we feel comfortable about communicating those results is that only patients with a positive scan get enrolled for the therapeutic portion and then we'll be able to track real time how those patients are doing.

Great. That will be good data to see. And then Lori or Thijs, I guess, any specific customer feedback from ASTRO anecdotes maybe that you can share on the reaction of the merger between Isoray and Viewpoint?

So I'll take that one first, I think we both probably have some things we'd like to share with you on that. I was really interested and excited to see the interest from the radiation oncologists in the space as the space has been primarily nuclear medicine was very interesting to see that it's really getting on the radar radiation oncologists and that they're very supportive of it and looking really toward it being a big part of their practices in the future. And then, Thijs, let me hand it to you.

Thanks, Lori. I mean, if this had been five years ago, I think we would have had a lot of raised eyebrows questioning what was going on here, but what's so exciting about this field is that these targeted radiopharmaceutical agents are proving that they're certainly robust within the U.S. framework, meaning payers are happy to reimburse for these therapies that really work. the physicians know how to prescribe them and get them reimbursed and administered, patients are benefiting from them. And as people look at the rapid uptake a bit seen with some of the pharmaceuticals that are beta emitters I think they're really leaning and looking forward to where we can go with the alpha emitters. So I think from the radiation oncologists perspective, I think they're really excited about this - about what we can do in an environment that's already been pretty clear for them. So they know how to administer a drug once it gets approved.

Okay, that's great color from both of you. Thank you. That does it for our questions.

Your next question is coming from [indiscernible] at B. Riley.

Hi, thanks for taking questions. This is [Brandon Carney] for Juan. I was wondering if you could provide a little bit more commentary on what kind of synergies you expect to see between ISR's brachytherapy business and viewpoints targeted alpha therapy approach?

No, it's a great question. And so one of the things that, hence we're really looking at our Viewpoint growth plans for the kind of talent we are looking to attract and retain and a lot of the roles that we're looking to do as we grow, we saw that there was an extraordinary number of really qualified people at Isoray that we could then have combining together. I think there's economies of both scale and scope as we look at how to combine and get larger and relating across so many key functions: safety, quality, regulatory, here's a whole range of them of these functional areas where as a growing emerging company and an established company merging together, we get to take the best of both. So we're really excited to see that. On the explicitly on this -- in the trenches, the sales reps our advisory has have fabulous relationships with physicians, and we are growing our relationships with physicians. So it's really important to be able to reach out to the doctors on both sides. It may sound like a tagline, treating cancer from the inside out, but that's really what we're doing. And I think for these docs, the ability to have brachytherapy and targeted alpha therapy together, they're seeing how excited they are.

Thanks. Thanks for the commentary. Just wondering on maybe, I guess, in the past have kind of viewed brachytherapy and radiopharmaceutical therapy is competing modalities. It kind of sounds like you don't view this that way. And I was just wondering if you could speak to that a little bit.

So they're not really competing and as we look at how patients get treated and how cancers get treated, and you think about melanoma as one example, right, where you've got -- if it's just something that's superficial on the skin, the dermatologists will cut it out. If it goes a little bit deeper, then they'll still try and explore and see where it gets to. But once these diseases get throughout the entire body, then you really need to kind of throw everything you can at it and deal with the right way. There's some chemotherapy approaches that can work in the tumor type immunotherapy, radiation oncology. And radiation oncology now is being split into radiation from the outside in or inside out. And as we look at that, there are all different ways of approaching combinations tend to work. We've had some great animal data showing that combinations to immunotherapy and our targeted alpha therapies really work well in the animal model and we expect that to roll over into humans as well. But in terms of how the physicians look at it, you've got this interesting intersection where you've got new pre-medicine doctors in some institutions. They are the ones who administer the injections, in other institutions at 3D oncologists. These are both different physician disciplines that both really care about patients and are both really keen to give the best possible therapy. They're both set upfront in terms of being licensed to administer the therapies. Each institution though has their own practices and policies and physician preferences. And so from our perspective, we want to make sure that we educate the market, we educate the physician base and the payer base to allow access to as many patients as possible.

Thanks. I guess one more question on this. When you talked about alpha therapy in the past, you talked about how alpha radiation offers all these advantages over beta and gamma. And I guess, I'm just wondering if you think that the gamma has a place or if there's some advantages to gamma that alpha is not addressing, so at least space for that brachytherapy answer.

So, I mean, brachytherapy is used in a very discreet kind of tumor. And so, for example, in the prostate, it's a very slow growing tumor. It's got different metabolic components than a lung tumor or neuroendocrine tumor would have. And so with each tumor, you need to make sure you characterize the right kind of treatment be that chemo surgery radiation, if the radiation is external versus internal. Right now you've got physicians that treat prostate cancer with external beam and with brachytherapy. And it depends on physician skill, what that patient looks like. We hope that every single patient that gets taken care of in the cancer setting gets a personalized approach. And it's really figuring out what exactly does that patient need and then prostate -- what exactly does that prostate need at which stage of disease. So it's really going to depend on what the patient gets, what -- we're adamant about with the Viewpoint technology platform. Is that by giving alpha particles into tumors where we know we can bind there and nowhere else, we get extraordinary results. Takes a single alpha particle to kill a cancer cell and it's a double stranded DNA break that's a very, very rapid response. There are other tumor types that respond well to gamma radiation over slower duration in period of time. Thankfully, we live in a really strong data driven world that really depends on evidence. And it's our job to make sure we deliver that evidence. But what we've seen so far in the animal model is that alphas are having extraordinary results once the tumor is identified and matched to that target alpha therapy. And we're committed to developing sort of tumor-by-tumor exactly the right treatment for each tumor.

Thanks. That's really helpful.

[Operator Instructions] There are no more questions at this time. There appear to be no further questions in queue. I would like to turn the floor over to Lori for any closing remarks.

Thank you everybody for joining us today. We are certainly very excited about this merger and look forward to communicating to you more and more about all the exciting news we'll have coming up. Have a great afternoon. Thanks. Bye-bye.